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ARS Pharmaceuticals submitted the Day 180 response for neffy (epinephrine nasal spray) Marketing Authorization Application to EMA's CHMP and entered a license agreement with CSL Seqirus for commercialization in Australia and New Zealand. The CHMP opinion on neffy is expected in the second quarter of 2024, addressing all identified issues and including results from a repeat dose study and updated nitrosamine testing. CSL Seqirus will handle regulatory approval, reimbursement, and commercialization, while ARS Pharma will manage manufacturing and supply.
